Effect of Delivery Route on PK of Sufentanil NanoTab

Phase 1

Completed

• Conditions: Pharmacokinetics

• Registration Number: NCT01639729
• Lead Sponsor: Talphera, Inc

Brief Summary

Determine whether the amount of drug absorbed is different if the tablet is placed under the tongue, placed between the cheek and gum, or swallowed.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Study First Submitted: 2012-07-11
• Study First Submitted QC: 2012-07-12
• Study First Posted: 2012-07-13
• Results First Submitted: 2013-11-25
• Results First Submitted QC: 2014-04-25
• Results First Posted: 2014-05-21
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-16
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• body mass index 18 - 30

Exclusion Criteria

• pregnant females
• smokers
• pulmonary disease
• sleep apnea

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Tmax	24 hours	time to maximum plasma concentration
AUC (0 - Inf)	24 hours	total amount of sufentanil absorbed
Cmax	24 hours	maximum plasma concentration
CST 1/2	24 hours	time for maximum plasma concentration to decrease by 50%

Trial Locations

Locations (1)

PRA; 🇺🇸 Lenexa, Kansas, United States